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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical
510(k) Number K070560
Device Name LRTM SURGICAL MESH
Applicant
LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG,  NJ  08876
Applicant Contact LORRAINE T MONTEMURRO
Correspondent
LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG,  NJ  08876
Correspondent Contact LORRAINE T MONTEMURRO
Regulation Number878.3300
Classification Product Code
FTM  
Date Received02/27/2007
Decision Date 06/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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